FDA Medical devices recall ·
Flamingo Funnel Small, Model Number SQ20012-01 recall
- Recall number
- Z-1924-2026
- Date
- (initiated March 16, 2026)
- Company / brand
- SurgiSmoke Solutions
2300 Myrtle Ave Ste 200, Saint Paul, MN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 2505 units total
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Flamingo Funnel Small, Model Number SQ20012-01
Why was it recalled?
Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 0860012888801; Lot 8264701
Distribution
Worldwide - US Nationwide distribution in the states of CA, CO, GA, MA, MD, ME, MN, NH, NY, OH, TN, TX, and UT. The country of Canada.
States: California Colorado Georgia Massachusetts Maryland Maine Minnesota New Hampshire New York Ohio Tennessee Texas Utah
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1924-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.